Several commercial medicaments in the form of pancreatic enzyme supplements are known for the treatment of pancreatic exocrine insufficiency. The active ingredients of these products are digestive enzymes, mainly amylase, lipase and protease, which are normally produced in the pancreas and excreted to the upper part of the small intestine (the duodenum). The enzymes used in such medicaments derive from bovine or swine pancreas.
WO 2005/115445 describes the use of the protease of SEQ ID NO: 1 and related proteases for pharmaceutical use, e.g. for the treatment of PEI.
WO 2006/136159 describes the use of the lipase of SEQ ID NO: 2 and related lipases for pharmaceutical use, e.g. for the treatment of PEI.
WO 2006/136161 describes the use of the amylases of SEQ ID NO: 3, 4, and 5 and related amylases for pharmaceutical use, e.g. for the treatment of PEI.
The protease derived from Nocardiopsis sp. (SEQ ID NO: 1), as well as its preparation and various industrial applications thereof are described in WO 88/03947 and WO 01/58276. Related proteases are described in WO 2004/111220, WO 2004/111222, WO 2004/111223, WO 2004/111221, WO 2005/035747, WO 2004/111219, WO 2005/123911, and JP 2003284571-A (GENESEQP:ADF43564).
The present invention provides novel proteases of an improved performance, e.g. of an improved apparent protein digestibility in vivo, an improved pH-ratio (pH5.6/pH8), and/or a reduced toxicity.